FABIANA AGENA
Projetos de Pesquisa
Unidades Organizacionais
Instituto Central, Hospital das Clínicas, Faculdade de Medicina
21 resultados
Resultados de Busca
Agora exibindo 1 - 10 de 21
conferenceObject A Critical Analysis of Equations for MPA Exposure in Patients Under EC-MPS and Tacrolimus(2017) DAVID-NETO, E.; TRIBONI, A.; RAMOS, F.; AGENA, F.; ROMANO, P.; FREITAS, G.conferenceObject Pharmacokinetics of Mycophenolic Acid (MPA) in Elderly Compared to Young Recipients in the First Year After Renal Transplantation. Data from the NEverOLd Trial(2015) ROMANO, P.; AGENA, F.; EBNER, P.; TRIBONI, A.; RAMOS, F.; GALANTE, N.; LEMOS, F.; SUMITA, N.; DAVID-NETO, E.conferenceObject Everolimus/low tacrolimus(TAC) compared to MPA/regularTAC for renal transplantation in the elderly recipient - preliminary analysis of the nEverOld trial(2016) DAVID-NETO, Elias; AGENA, Fabiana; RAMOS, Fernanda; TRIBONI, Ana H. K.; ALTONA, Marcelo; COELHO, Venceslau; GALANTE, Nelson Z.; LEMOS, Francine B. C.- Development of an Abbreviated Mycophenolic Acid Area Under the Time-Concentration Curve for Renal Transplant Patients Under Enteric-Coated Mycophenolate Sodium: A Comparison With Critical Analysis of Available Equations(2018) DAVID-NETO, Elias; TRIBONI, Ana Heloisa; RAMOS, Fernanda; AGENA, Fabiana; ROMANO, PaschoalinaBackground: Enteric-coated mycophenolate sodium is frequently used in renal transplantation. The pharmacokinetic profile of mycophenolic acid (MPA) shows a broad range of time-tomaximum concentration (T-max) that limits the use of a single MPA concentration to calculate the area under the time-concentration curve (AUC). For both research and clinical MPA monitoring, measuring a complete AUC is troublesome to the center and patients. Methods: We obtained 171 complete MPA-AUC(12h) (0, 20, 40, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes) from 59 adult (54 +/- 16 years) patients (29 men and 43 whites) who have been receiving stable doses of tacrolimus/enteric-coated mycophenolate sodium and steroids. We used the 59 curves drawn at 31 +/- 4 days after transplantation to develop the abbreviated equations, and the remaining 112 curves drawn at 109 +/- 59 days were used to validate them. We used 5 other proposed equations to estimate MPA-AUC (eAUC) (4 with enzyme-multiplied immunoassay technique assay and one with high-performance liquid chromatography [HPLC]) and then used these results to compare with our measured AUC, the bias, and the 10% and 30% accuracy. MPA was measured by ultraperformance liquid chromatography coupled to a tandem mass spectrometry, and AUC was calculated by the trapezoidal rule. Results: For both MPA-measuring methods, enzyme-multiplied immunoassay technique and ultraperformance liquid chromatography coupled to a tandem mass spectrometry, the Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP) equations, and others that measure MPA up to 6 hours after the dose had an acceptable low bias with more results in the 10%-30% range than those using data collected until 4 hours. A highly adequate eAUC is obtained using blood collected at 8 hours. Conclusions: This analysis offers blood-sampling alternatives for MPA monitoring depending on the precision needed.
conferenceObject Pharmacokinetics of Everolimus (EVL) in Elderly Recipients Under Low-Tacrolimus(TAC)/Everolimus in the First Year After Renal Transplantation. Data from the NEverOLd Trial(2015) DAVID-NETO, E.; ROMANO, P.; AGENA, F.; EBNER, P.; TRIBONI, A.; RAMOS, F.; GALANTE, N.; LEMOS, F.conferenceObject EVALUATION OF MDRD4, CKD-EPI AND MODIFIED COCKCROFT-GAULT EQUATIONS TO ESTIMATE GLOMERULAR FILTRATION RATE IN THE ELDERLY RENAL TRANSPLANTED RECIPIENTS(2015) DAVID-NETO, Elias; KAMADA, Triboni Ana Heloisa; RAMOS, Fernanda; AGENA, Fabiana; BRAMBATE, Carvalhinho Lemos Francine; TATIT, Sapienza Marcelo; ALTONA, Marcelo; NAHAS, William Carlos- Longitudinal Pharmacokinetics of Mycophenolic Acid in Elderly Renal Transplant Recipients Compared to a Younger Control Group: Data from the nEverOld Trial(2019) ROMANO, Paschoalina; AGENA, Fabiana; EBNER, Persio de Almeida Rezende; SUMITA, Nairo Massakazu; TRIBONI, Ana Heloisa Kamada; RAMOS, Fernanda; GARCIA, Marcio dos Santos; DUARTE, Nilo Jose Coelho; LEMOS, Francine Brambate Carvalhinho; GALANTE, Nelson Zocoler; DAVID-NETO, EliasBackground and ObjectivesElderly patients are increasingly likely to be recipients of transplants. However, the pharmacokinetics of mycophenolic acid (MPA) in this population are yet to be studied in detail. The objective of this study was to assess whether there were differences in MPA pharmacokinetic parameter values between elderly recipients and younger-adult recipients during the 6months immediately following renal transplantation.MethodsIn this analysis, the longitudinal 12-h pharmacokinetics of MPA, administered as enteric-coated mycophenolate sodium (EC-MPS), were evaluated in 44 elderly renal transplant recipients and compared with the corresponding pharmacokinetics of MPA in 31 younger adult recipients. Measurements were performed at 7, 30, 60, 90, and 180days post-transplantation. All patients received tacrolimus and prednisone.ResultsThe elderly patients were 30years older than the younger controls, with a predominance of males and Caucasians. Elderly patients had lower serum albumin than the younger controls during the first 6months after transplantation. The mean estimated total body MPA clearance of the elderly recipients was not significantly different from that of the controls at any analyzed time point (the mean clearance across all time points was 0.310.17 vs 0.300.25L/h/kg). MPA exposure, as evaluated from the area under the 12-h time versus measured MPA concentration (adjusted for dose/body weight) curve, did not differ between the groups at any time point (mean exposure across all time points was 4.68 +/- 3.61 vs 5.95 +/- 4.29 mu gh/mL per mg/kg for the elderly recipients and the controls).ConclusionsThese data show that the pharmacokinetics of MPA in elderly renal transplant recipients were no different to those of younger-adult recipients in this study population.Clinicaltrials.govp id=""Par5000"">NCT 01631058.
- Longitudinal Pharmacokinetics of Everolimus When Combined With Low-level of Tacrolimus in Elderly Renal Transplant Recipients(2017) DAVID-NETO, Elias; AGENA, Fabiana; RAMOS, Fernanda; TRIBONI, Ana Heloisa Kamada; ROMANO, Paschoalina; EBNER, Persio de Almeida Rezende; COELHO, Venceslau; GALANTE, Nelson Zocoler; LEMOS, Francine Brambate CarvalhinhoBackground Although the proportion of elderly patients among renal transplant recipients has increased, pharmacokinetic (PK) studies of immunosuppressants rarely include older patients. Methods We studied 12-hour everolimus (EVL) PK in 16 elderly renal transplant recipients (all whites; 10 men; mean age, 64 2 years (61-71 years), in 4 separate timepoints (at 7, 30, 60, and 150 days) after EVL introduction, corresponding to a mean postrenal transplantation day: PK1 (43 4 days), PK2 (65 +/- 7 days), PK3 (106 +/- 17 days), and PK4 (206 +/- 40 days). Patients received EVL (target trough level (C-trough, 3-8 ng/mL), prednisone, and tacrolimus (TCL) (target C-trough, 2-5 ng/mL). Results Mean TCL-C-trough was 7.2 +/- 3.8, 4.9 +/- 2.2, 4.9 +/- 2.2, and 4.5 +/- 1.2 ng/mL at PK1, PK2, PK3, and PK4, respectively. There were no differences among timepoints for mean EVL daily dose (data shown as PK3) (3.5 +/- 1.3 mg/d), C-trough (4.7 +/- 2.5 ng/mL), AUC(0-12h) (106 +/- 51 ng/h per mL), C-average (8.8 +/- 4.2 ng/mL), C-max (19.2 +/- 9.7 ng/mL), apparent Half-life (11.7 +/- 4.2 hours), estimated total body clearance (0.39 +/- 0.27 L/h), or fluctuation (166 +/- 65%). Also, none of those PK parameters differed statistically when adjusted for body weight. EVL-C-trough showed a very high correlation (r(2) = 0.849) with AUC(0-12h). Conclusions Our data indicate that elderly renal transplant recipients starting EVL 1 month after transplantation along with a steady-state TCL level, present stable EVL-PK parameters without significant changes in dose or exposure during the first 6 months after renal transplantation.
conferenceObject A Randomized, Prospective Study Comparing Everolimus/low Tacrolimus With Regular Tacrolimus/MPS for the Elderly Renal Transplant Recipients(2014) DAVID-NETO, E.; GALANTE, N.; ALTONA, M.; PAULA, F.; TRIBONI, A.; RAMOS, F.; AGENA, F.; NAHAS, W.conferenceObject Pharmacokinetics of Tacrolimus (TAC) in Elderly Compared to Young Recipients in the First Year After Renal Transplantation. Data from the NEverOLd Trial(2015) DAVID-NETO, E.; ROMANO, P.; TRIBONI, A.; AGENA, F.; EBNER, P.; RAMOS, F.; GALANTE, N.; LEMOS, F.
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